Local Coverage Determination for Implantable …

1 Local Coverage Determination (LCD) for Implantable Infusion Pump for the Treatment of Chronic Intractable Pain (L31254). Contractor Information Contractor Name Contractor Number Contractor Type First Coast Service Options, 09102 MAC - Part B. Inc. Back to Top LCD Information Document Information LCD ID Number L31254. Primary Geographic Jurisdiction Florida LCD Title Implantable Infusion Pump for the Treatment of Chronic Intractable Pain Oversight Region Region IV. Contractor's Determination Number 95990. Original Determination Effective Date AMA CPT/ADA CDT Copyright Statement For services performed on or after 09/30/2010. CPT codes, descriptions and other data only are copyright 2011 American Medical Original Determination Ending Date Association (or such other date of publication of CPT).

2 All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Revision Effective Date Terminology, (CDT) (including procedure For services performed on or after 01/01/2012. codes, nomenclature, descriptors and other data contained therein) is copyright by the Revision Ending Date American Dental Association. 2002, 2004. American Dental Association. All rights reserved. Applicable FARS/DFARS apply. CMS National Coverage Policy Language quoted from CMS National Coverage Determination (NCDs) and Coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and Coverage provisions in interpretive manuals are not subject to the LCD. Review Process (42 CFR [b] and 42 CFR 426 [Subpart D]).

3 In addition, an administrative law judge may not review an NCD. See 1869(f)(1)(A)(i) of the Social Security Act. Printed on 2/3/2012. Page 1 of 6. Unless otherwise specified, italicized text represent quotation from one or more of the following CMS sources: CMS Manual Systems, Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section Indications and Limitations of Coverage and/or Medical Necessity This Local Coverage Determination (LCD) addresses the use of an Implantable infusion pump for treatment of chronic intractable pain and is based on the Medicare National Coverage Determinations (NCD) Manual, Infusion Pumps (Section ). The Implantable infusion pump is a drug delivery system that is used to deliver a solution containing a parenteral drug(s) under continuous or intermittent infusion with a regulated flow rate.

4 Its purpose is to deliver a therapeutic level of a drug to a specific site within the body. An Implantable infusion pump is covered when used to administer opioid drugs ( , morphine) intrathecally or epidurally for treatment of severe chronic intractable pain of malignant or nonmalignant origin in patients who have a life expectancy of at least 3 months, and have proven unresponsive to less invasive medical therapy as determined by the following criteria: The patient's history must indicate that he/she would not respond adequately to noninvasive methods of pain control, such as systemic opioids (including attempts to eliminate physical and behavioral abnormalities which may cause an exaggerated reaction to pain).

5 And A preliminary trial of intraspinal opioid drug administration must be undertaken with a temporary intrathecal/epidural catheter to substantiate adequately acceptable pain relief and degree of side effects (including effects on the activities of daily living) and patient acceptance. Determinations may be made on Coverage of other uses of implanted infusion pumps if the contractor's medical staff verifies that: The drug is reasonable and necessary for the treatment of the individual patient;. It is medically necessary that the drug be administered by an implanted infusion pump;. and, The Food and Drug Administration (FDA)-approved labeling for the pump must specify that the drug being administered and the purpose for which it is administered is an indicated use for the pump.

6 Additionally, antispasmodic drugs for severe spasticity used concomitantly for treatment of chronic intractable pain must meet the following NCD criteria: An Implantable infusion pump is covered when used to administer anti-spasmodic drugs intrathecally ( , baclofen) to treat chronic intractable spasticity in patients who have proven unresponsive to less invasive medical therapy as determined by the following criteria: Printed on 2/3/2012. Page 2 of 6. As indicated by at least a 6-week trial, the patient cannot be maintained on noninvasive methods of spasm control, such as oral anti-spasmodic drugs, either because these methods fail to control adequately the spasticity or produce intolerable side effects, and prior to pump implantation, the patient must have responded favorably to a trial intrathecal dose of the anti- spasmodic drug.

7 Back to Top Coding Information Bill Type Codes: Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that Coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. 999x Not Applicable Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory;. unless specified in the policy services reported under other Revenue Codes are equally subject to this Coverage Determination .

8 Complete absence of all Revenue Codes indicates that Coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes. CPT/HCPCS Codes GroupName ELECTRONIC ANALYSIS OF PROGRAMMABLE, IMPLANTED PUMP. FOR INTRATHECAL OR EPIDURAL DRUG INFUSION (INCLUDES. 62367. EVALUATION OF RESERVOIR STATUS, ALARM STATUS, DRUG. PRESCRIPTION STATUS); WITHOUT REPROGRAMMING OR REFILL. ELECTRONIC ANALYSIS OF PROGRAMMABLE, IMPLANTED PUMP. FOR INTRATHECAL OR EPIDURAL DRUG INFUSION (INCLUDES. 62368. EVALUATION OF RESERVOIR STATUS, ALARM STATUS, DRUG. PRESCRIPTION STATUS); WITH REPROGRAMMING. ELECTRONIC ANALYSIS OF PROGRAMMABLE, IMPLANTED PUMP. FOR INTRATHECAL OR EPIDURAL DRUG INFUSION (INCLUDES.)

9 62369. EVALUATION OF RESERVOIR STATUS, ALARM STATUS, DRUG. PRESCRIPTION STATUS); WITH REPROGRAMMING AND REFILL. 62370. Printed on 2/3/2012. Page 3 of 6. ELECTRONIC ANALYSIS OF PROGRAMMABLE, IMPLANTED PUMP. FOR INTRATHECAL OR EPIDURAL DRUG INFUSION (INCLUDES. EVALUATION OF RESERVOIR STATUS, ALARM STATUS, DRUG. PRESCRIPTION STATUS); WITH REPROGRAMMING AND REFILL. (REQUIRING PHYSICIAN'S SKILL). REFILLING AND MAINTENANCE OF Implantable PUMP OR. RESERVOIR FOR DRUG DELIVERY, SPINAL (INTRATHECAL, 95990. EPIDURAL) OR BRAIN (INTRAVENTRICULAR), INCLUDES. ELECTRONIC ANALYSIS OF PUMP, WHEN PERFORMED;. REFILLING AND MAINTENANCE OF Implantable PUMP OR. RESERVOIR FOR DRUG DELIVERY, SPINAL (INTRATHECAL, 95991 EPIDURAL) OR BRAIN (INTRAVENTRICULAR), INCLUDES.

10 ELECTRONIC ANALYSIS OF PUMP, WHEN PERFORMED;. REQUIRING PHYSICIAN'S SKILL. ICD-9 Codes that Support Medical Necessity N/A. XX000 Not Applicable Diagnoses that Support Medical Necessity N/A. ICD-9 Codes that DO NOT Support Medical Necessity N/A. XX000 Not Applicable ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation Diagnoses that DO NOT Support Medical Necessity N/A. Back to Top General Information Documentations Requirements Medical record documentation maintained by the performing provider must clearly indicate the medical necessity of the services being billed as outlined under the Indications and Limitations of Coverage and/or Medical Necessity section of this LCD and made available to First Coast Service Options, Inc.